FDA has announced the release of a draft guidance document concerning the necessary elements and contents of a complete premarket approval (PMA) application and the key decisions that are made during the filing process. The draft guidance applies to all devices reviewed in a PMA application and, if accepted as final, will replace FDA's original 2003 PMA guidance review criteria and checklist. The draft guidance is intended to enhance the consistency of acceptance and filing decisions and to help applicants better understand the types of information FDA needs to conduct a substantive review of a PMA. Unlike FDA's original 2003 guidance on PMA reviews, the new draft guidance separates the criteria review for PMA filings into two areas: (1) acceptance criteria, and (2) filing criteria. During an acceptance criteria review, the draft guidance states that FDA will review the completeness of the application and inform the applicant in a written response within the first 15 calendar days of receipt of the application whether any elements are missing, and if so, identify the missing elements. Comments on the draft guidance should be submitted to the FDA by September 14, 2012.